An Open Label Study Evaluating the Effectiveness of Omega Q Plus® Resveratrol at Increasing Blood Levels of CoQ10

NCT ID: NCT02415114

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-06-30

Brief Summary

The primary objective of this study is to assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days.The secondary objective of the study is to determine if statin use has an impact on the blood levels of Coenzyme Q10 when administered Omega Q Plus® Resveratrol for 28 days. The safety objectives will include assessment of safety evaluations as determined by:

• laboratory tests - CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin
• vital signs - heart rate and blood pressure
• adverse events

Conditions

CoQ10 Blood Levels; CoQ10 Blood Levels With Statin Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Population

Healthy Population with Omega Q Plus Resveratrol (with 50mg CoQ10)

Group Type: ACTIVE_COMPARATOR

Omega Q Plus Resveratrol (with 50mg CoQ10)

Intervention Type: DIETARY_SUPPLEMENT

Omega Q Plus Resveratrol (with 50mg CoQ10)

Population taking Statins

Population taking Statins with Omega Q Plus Resveratrol (with 50mg CoQ10)

Group Type: ACTIVE_COMPARATOR

Omega Q Plus Resveratrol (with 50mg CoQ10)

Intervention Type: DIETARY_SUPPLEMENT

Omega Q Plus Resveratrol (with 50mg CoQ10)

Interventions

Omega Q Plus Resveratrol (with 50mg CoQ10)

Omega Q Plus Resveratrol (with 50mg CoQ10)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Male or female 45 years of age or older
• BMI <30kg/m2 (±1 kg/m2)
• If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).

OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). Double-barrier method. Non-hormonal intrauterine devices. Vasectomy of partner. Non-heterosexual lifestyle (same-sex relationship).

• CoQ10 levels between 0.5 mcg/mL - 1 mcg/mL
• Agree to maintain current level of physical activity, caffeine consumption habits, alcohol consumption habits, smoking habits and dietary habits throughout the study
• Has given voluntary, written, informed consent to participate in the study

• Adults on statin medications for at least 3 months and are otherwise healthy
• Male or female 45 years of age or older
• BMI <30kg/m2 (±1 kg/m2)
• If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).

OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). Double-barrier method. Non-hormonal intrauterine devices. Vasectomy of partner.Non-heterosexual lifestyle (same-sex relationship)

• Agree to maintain current level of physical activity, caffeine consumption habits, alcohol consumption habits, smoking habits and dietary habits throughout the study
• Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Unstable medical conditions
• History of atrial or ventricular arrhythmia
• History of atherosclerosis
• History of seizures
• Type I or Type II diabetes
• Use of illicit drugs or history of alcohol or drug abuse within the last 6 months
• Currently having more than 2 standard alcoholic drinks per day
• Medical use of marijuana
• Clinically significant abnormal laboratory results at screening
• History or a current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subject with cancer in full remission more than 5 years after diagnosis are acceptable
• Use of prescription blood thinner medications (i.e. warfarin etc.)
• Use of products containing CoQ10 other than vitamins or minerals within 2 weeks of randomization
• Uncontrolled hypertension defined as untreated systolic blood pressure >160 mmHg or/or diastolic blood pressure >100mmHg
• Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
• Significant abnormal liver function as defined as AST or/ALT > 2 times the upper limit of normal (ULN), and/or bilirubin > 2 times the ULN
• Participation in a clinical research trial within 30 days prior to randomization
• Allergy or sensitivity to study supplement ingredients
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Conditions that in the opinion of the investigator may suggest that the subject may be unsuitable for this study
• Unstable medical conditions
• Use of illicit drugs or history of alcohol or drug abuse within the last 6 months
• Currently having more than 2 standard alcoholic drinks per day
• Medical use of marijuana
• Clinically significant abnormal laboratory results at screening (except elevated levels of creatinine kinase that will be considered based on the opinion of the Investigator)
• History or a current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subject with cancer in full remission more than 5 years after diagnosis are acceptable
• History of muscle disease unrelated to statin use
• History of seizures
• Any acute disease that may influence plasma CoQ10 levels
• Subjects on background CoQ10 therapy during the last 3 months
• Use of products containing CoQ10 other than vitamins or minerals within 2 weeks of randomization
• Uncontrolled hypertension defined as untreated systolic blood pressure >160 mmHg or/or diastolic blood pressure >100mmHg
• Use of prescription blood thinner medications (i.e. warfarin etc.)
• Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
• Significant abnormal liver function as defined as AST or/ALT > 2 times the upper limit of normal (ULN), and/or bilirubin > 2 times the ULN
• Participation in a clinical research trial within 30 days prior to randomization
• Allergy or sensitivity to study supplement ingredients
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Healthy Directions, LLC

UNKNOWN

Sponsor Role: collaborator

KGK Science Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tetyana Pelipyagina, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Synergize Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

15COHH

Identifier Type: -

Identifier Source: org_study_id